510(k) K173079 ยท LNH System, Nuclear Magnetic Resonance Imaging
Ingenia 1.5T, Ingenia 1 5T S, Ingenia 1.5T CX, Ingenia 3.0T CX R5.4
| Applicant | Philips Medical Systems Nederland B.V., Best Noord-Brabant, NL |
| Decision | Substantially Equivalent, Apr 4, 2018 |
| Received | Sep 29, 2017 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K173079
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 27, 2026 | Philips North America Philips Achieva 1.5T Initial system with MR Elastography (MRE).
1. Model Number (REF): 781178. Open, Classified |
LNH | None listed |
| Apr 27, 2026 | Philips North America Philips Ingenia 1.5T with MR Elastography (MRE).
1. Model Number (REF): 781315.
2. Model Number (REF): 781341.
3. Model Number (REF): 781396.
4. Model Number (REF): 782115.
510(k) Numbers: K Open, Classified |
LNH | None listed |
| Apr 27, 2026 | Philips North America Philips Ingenia 3.0T CX with MR Elastography (MRE).
1. Model Number (REF): 781271.
2. Model Number (REF): 782105.
510(k) Numbers: K173079, K183063, K193215, K213583, K223458, K251397, K251808. Open, Classified |
LNH | None listed |
| May 16, 2025 | Philips North America Llc Product Name: SmartPath to dStream for 1.5T;
Model Numbers: (1) 781260, (2) 782112, (3) 782146 Open, Classified |
LNH | None listed |
| May 16, 2025 | Philips North America Llc Product Name: SmartPath to dStream for 3.0T;
Model Number: 782145 Open, Classified |
LNH | None listed |
| May 16, 2025 | Philips North America Llc Product Name: SmartPath to dStream for XR and 3.0T;
Model Numbers: (1) 781270, (2) 782113; Open, Classified |
LNH | None listed |
| May 16, 2025 | Philips North America Llc Product Name: SmartPath to Ingenia Elition X;
Model Numbers: (1) 782118, (2) 782144; Open, Classified |
LNH | None listed |
| Nov 21, 2023 | Philips North America Llc Achieva 1.5T Open, Classified |
LNH | None listed |
| Nov 21, 2023 | Philips North America Llc Achieva 1.5T Conversion Open, Classified |
LNH | None listed |
| Nov 21, 2023 | Philips North America Llc Ingenia 1.5T CX Open, Classified |
LNH | None listed |
| Nov 21, 2023 | Philips North America Llc Intera 1.5T Open, Classified |
LNH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.